5 Amendments of Aldo PATRICIELLO related to 2014/0256(COD)
Amendment 13 #
Proposal for a regulation
Recital 4
Recital 4
(4) As a consequenceresult of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress, determining the situations in which post- authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.
Amendment 14 #
Proposal for a regulation
Recital 5
Recital 5
(5) It is of particularfundamental importance that the Commission carries out appropriate consultations during its preparation of delegated acts, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 15 #
Proposal for a regulation
Recital 6
Recital 6
(6) In order tothe interests of ensureing uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8. ___________ 8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 16 #
Proposal for a regulation
Recital 3
Recital 3
(3) The costs of the procedures and services associated with the operation of this Regulation need to be recovered from those making medicinal products available on the market and from those seeking authorisation. It is appropriate to establish certain principles applicable to fees payable to the Agency, including the need to take into account, as appropriate, the specific needs for SMEsThe fees payable to the Agency should ensure that it functions normally and independently. The provisions regulating fees should be brought into line with the Treaty of Lisbon.
Amendment 17 #
Proposal for a regulation
Recital 5
Recital 5
(5) It is of particular importance that the Commission carries out appropriate consultations during its preparation of delegated acts, including at expert levelDuring the initial stage of the preparatory work, the Commission is requested to carry out consultations with panels of experts, who should be as independent as possible. The appointment of these experts should also secure the consent of the European Parliament. The Commission, when preparing and drawing- up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council and should examine any feedback.